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This Study is to Evaluate Safe and Effective Treatment Dose of OBI-888 in Patients With Locally Advanced or Metastatic Solid Tumors.

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ClinicalTrials.gov Identifier: NCT03573544
Recruitment Status : Recruiting
First Posted : June 29, 2018
Last Update Posted : September 6, 2019
Sponsor:
Information provided by (Responsible Party):
OBI Pharma, Inc

Brief Summary:
The purpose of this study is to establish the maximum tolerated dose (MTD) of OBI-888 as monotherapy. And to characterize the safety and preliminary clinical activity profile of the MTD dose of OBI-888 administered as monotherapy in patients with locally advanced or metastatic solid tumors.

Condition or disease Intervention/treatment Phase
Metastatic Solid Tumors Locally Advanced Solid Tumors Drug: OBI-888 Device: Globo H IHC Assay Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 168 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II, Open-Label, Dose Escalation and Cohort Expansion Study Evaluating the Safety, Pharmacokinetics (PK), Pharmacodynamics (PD), and Therapeutic Activity of OBI-888 in Patients With Locally Advanced or Metastatic Solid Tumors.
Actual Study Start Date : May 7, 2018
Estimated Primary Completion Date : May 10, 2021
Estimated Study Completion Date : June 10, 2021

Arm Intervention/treatment
Experimental: OBI-888 Escalation Phase
Part A: Three cohorts of escalating dose levels of OBI-888 5, 10, and 20 mg/kg liquid form for intravenous infusion to establish maximum tolerated dose (MTD).
Drug: OBI-888
For the dose-escalation phase, OBI-888 will be given weekly at the dose levels of 5, 10, and 20 mg/kg.

Device: Globo H IHC Assay
This assay will be used to identify eligible patients who may clinically benefit from the OBI-888 treatment, defined by Globo H expression.

Experimental: OBI-888 Expansion Phase
Part B: Five cohorts at dose level 20 mg/kg of liquid form OBI-888 for intravenous infusion.
Drug: OBI-888
For the dose-expansion phase, OBI-888 will be given weekly at 20 mg/kg dose level.

Device: Globo H IHC Assay
This assay will be used to identify eligible patients who may clinically benefit from the OBI-888 treatment, defined by Globo H expression.




Primary Outcome Measures :
  1. Measurement of dose-limiting toxicities (DLTs) [ Time Frame: first 28 days in escalation phase ]
    Percentage of patients with dose-limiting toxicities (DLTs) observed

  2. Identification of a maximum tolerated dose of OBI-888 [ Time Frame: Week 1 to Week 53 ]
    Percentage of patients with adverse events/serious adverse events and laboratory abnormalities as graded by NCI CTCAE version 4.03


Secondary Outcome Measures :
  1. Measurement of preliminary clinical activity profile (objective response rate [ORR], clinical benefit rate [CBR], duration of response (DOR), and PFS) of OBI-888 in patients. [ Time Frame: Week 1 to Week 53 ]
    Percentage of patients with ORR, CBR, duration of response (DOR), and PFS per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) and immune-related response criteria (irRC)

  2. Measurement of the OBI-888 immunogenicity (anti-drug antibodies [ADAs]) in patients. [ Time Frame: Week 1 to Week 53 ]
    Percentage of patients with anti-OBI-888 antibodies in blood.

  3. Pharmacokinetics (PK) - Maximum serum concentrations (Cmax) [ Time Frame: Week 1 ]
    PK parameters will be calculated using a non-compartmental method from the PK samples collected on Dose 1

  4. PK - total exposure Area Under Curve (AUC) [ Time Frame: Week 1 ]
    PK parameters will be calculated using a non-compartmental method from the PK samples collected on Dose 1

  5. PK - elimination half-life (t1/2), [ Time Frame: Week 1 ]
    PK parameters will be calculated using a non-compartmental method from the PK samples collected on Dose 1

  6. PK - clearance (Cl) [ Time Frame: Week 1 ]
    PK parameters will be calculated using a non-compartmental method from the PK samples collected on Dose 1

  7. PK - time to reach maximum concentration (Tmax) [ Time Frame: Week 1 ]
    PK parameters will be calculated using a non-compartmental method from the PK samples collected on Dose 1

  8. PK - volume of distribution (Vd) [ Time Frame: Week 1 ]
    PK parameters will be calculated using a non-compartmental method from the PK samples collected on Dose 1



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients must meet all of the following criteria in order to be included in the study:

  1. Male or female patients, 18 years of age or older at the time of consent.
  2. Provide written informed consent prior to performing any study-related procedure.
  3. Histologically or cytologically confirmed patients with advanced or metastatic solid tumors for both Dose Escalation and Expansion cohort.
  4. Patients must have been treated with established standard-of-care therapy, or physicians have determined that such established therapy is not sufficiently efficacious, or patients have declined to receive standard-of-care therapy.
  5. Measurable disease (i.e., at least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1.
  6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  7. Adequate organ function defined as:

    • Hepatic:

      • Serum alanine aminotransferase (ALT) ≤3 × upper limit of normal (ULN), ≤5 × ULN in the presence of liver metastases
      • Serum aspartate aminotransferase (AST) ≤3 × ULN, ≤5 × ULN in presence of liver metastases
      • Serum bilirubin ≤1.5 × ULN
    • Renal:

      - Creatinine clearance >30 mL/minute using Cockcroft Gault equation

    • Hematologic:

      • Absolute neutrophil count ≥1000/µL
      • Platelets ≥75,000/µL
      • Hemoglobin ≥8 g/dL
  8. Patient is willing and able to comply with all protocol required assessments, visits, and procedures, including pretreatment tumor biopsy. Archival tumor biopsies are acceptable at baseline.
  9. Females of childbearing potential must have negative serum pregnancy test prior to starting study therapy, and agree to use a reliable form of contraceptive during the study treatment period and for at least 120 days following the last dose of study drug.

    Subject not of childbearing potential (i.e., permanently sterilized, postmenopausal) can be included in study. Postmenopausal is defined as 12 months with no menses without an alternative medical cause.

    Male patients must agree to use an adequate method of contraception during the study treatment period and for at least 120 days following the last dose of study drug.

  10. Cannot be breast feeding.
  11. Patients in Part B (Cohort expansion) must have a qualifying, documented Globo H H-score in sponsor-selected tumor types to be enrolled in the respective cohort:

Exclusion Criteria:

Patients meeting any of the following criteria are ineligible to participate in this study:

  1. Less than 3 weeks, from prior cytotoxic chemotherapy or radiation therapy; and less than 5 half-lives or 6 weeks, whichever is shorter, prior to the first dose of OBI-888.
  2. Has undergone a major surgical procedure (as defined by the investigator) or significant traumatic injury within 28 days prior to the first dose of OBI-888.
  3. Presence of an active autoimmune or inflammatory disease requiring systemic treatment within the past 2 months or a documented history of clinically severe autoimmune disease that requires systemic steroids or other immunosuppressive medications. Local steroid injections, intermittent use of topical, inhaled, ophthalmologic, intra-articular, topical, or intranasal corticosteroids, or systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or equivalent would not be excluded from the study.
  4. Presence of primary immunodeficiency or receiving systemic steroids of >10 mg/day of prednisone or equivalent or other immunosuppressive agents within 14 days prior to the first dose of OBI 888.
  5. Has active bacterial, viral, fungal, or mycobacterial infection requiring systemic therapy, including known infection with human immunodeficiency virus (HIV) or active infection with hepatitis B virus or hepatitis C virus.
  6. Patients with a history of solid organ transplant.
  7. Unresolved toxicities from prior anticancer therapy, defined as having not resolved to Grade 0 or 1 (using National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] version 4.03), except for alopecia and laboratory values listed in the inclusion criteria.
  8. Receipt of any prior therapy targeting Globo H.
  9. Known hypersensitivity to OBI 888 or its excipients.
  10. Has known, untreated central nervous system metastases and/or leptomeningeal metastases.
  11. Any medical co morbidity or psychiatric illness that is life threatening or, in the opinion of the Investigator, renders the patient unsuitable for participation in a clinical trial due to possible noncompliance, would place the patient at an unacceptable risk and/or potential to affect interpretation of results of the study.
  12. Is receiving any concurrent prohibited medication

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03573544


Contacts
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Contact: Ryan Hua +886-2-2786-6589 ext 207 khhua@obipharma.com

Locations
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United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
OBI Pharma, Inc
Investigators
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Principal Investigator: Apostolia Tsimberidou, MD, PHD M.D. Anderson Cancer Center

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Responsible Party: OBI Pharma, Inc
ClinicalTrials.gov Identifier: NCT03573544     History of Changes
Other Study ID Numbers: OBI-888-001
First Posted: June 29, 2018    Key Record Dates
Last Update Posted: September 6, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Keywords provided by OBI Pharma, Inc:
mAbs
monoclonal antibodies
Additional relevant MeSH terms:
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Neoplasms